NCPA submits comments in support of compounding to congressional committees

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday submitted comments to two congressional committees holding separate hearings examining the meningitis outbreak at the New England Compounding Center, including the the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations and to the U.S. Senate Committee on Health, Education, Labor & Pensions, respectively.

The NCPA’s comments outline the differences between customized medications that prescribers ask independent pharmacists to prepare through traditional compounding for specific patients versus the large-scale manufacturing that NECC appears to have engaged in and allegedly led to the meningitis cases.

A recent survey of 400 independent community pharmacists found that while 85% provided traditional compounding, 62% said it makes up no more than 5% of their business. In addition, 72% provided only nonsterile medications, as opposed to sterile medications mass-produced by the NECC.

“Independent community pharmacists are working constructively with policy-makers to help ensure that a tragedy like this doesn’t happen again,” stated NCPA CEO Douglas Hoey. “The overwhelming majority of independent community pharmacies offer traditional compounding services as a small, but vital, niche service that meets patients’ specific health needs often reduces costs and alleviates drug shortages. Congress and others addressing the meningitis outbreak should preserve patients’ access to traditional compounding services while taking any appropriate action to rein in any rogue drug manufacturers like [the] NECC.”

Hoey added, “Ultimately, we want to avoid scenarios where independent community pharmacists are not able to help in timely and often profound ways. In addition to the help they provide individual patients every day, a couple of years ago during the H1N1 outbreak, these local healthcare providers alleviated a critical shortage of the liquid version of Tamiflu for children through traditional compounding.”

According to the NCPA,independent community pharmacists typically provide compounding services to fulfill special needs that cannot be met by commercially available medications. Examples include hormone replacement medications, flavoring medications for pediatric patients, progesterone suppositories to prevent miscarriages and medications for cystic fibrosis patients.

The Food and Drug Administration has previously said in congressional testimony that “we believe that the vast majority of pharmacies engaging in pharmacy compounding provide a valuable medical service that is an integral part of our modern healthcare system."

The NCPA expressed support for a state-based approach to informing patients (e.g., labeling) that a compounded drug was made by the pharmacist at the behest of a prescriber, but would oppose any labeling requirement suggesting a compounded drug was “unapproved, potentially unsafe or not prepared correctly."

In the case of the NECC, the NCPA noted, existing state and federal laws and regulatory bodies were sufficient enough, if properly enforced and utilized, to have averted or at least lessened the impact of the tragedy that had occurred.

FDA wants more oversight of compounding pharmacies

NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

According to a draft of testimony submitted ahead of a hearing before the House Committee on Energy and Commerce, Hamburg detailed the FDA’s response to the outbreak, linked to contaminated steroid drugs from the New England Compounding Center in Framingham, Mass., and also the agency’s limited ability to regulate pharmacy compounding.

"[The] FDA’s ability to take action against compounding that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to [the] FDA’s authority to inspect pharmacies and take appropriate enforcement actions," read a draft of Hamburg’s testimony submitted before the hearing.

As of Monday, the oubreak, linked to doses of the steroid methylprednisolone acetate contaminated with fungus, had sickened 438 patients and killed 32, according to the Centers for Disease Control and Prevention.

In her testimony, Hamburg suggested greater federal oversight of what she called "nontraditional compounding," meaning pharmacy compounding of drugs that could potentially pose higher risks to patients for various reasons, such as sterile compounding, shipments of compounded drugs between states or dispensing through third parties. She said the FDA should have the power to collect and test samples of compounded drugs and examine compounding pharmacies’ records, as it does when inspecting other manufacturers and to require that pharmacies involved with nontraditional compounding register with the agency.

"Nontraditional compounding should, because of the higher risk presented, be subject to a greater degree of oversight, with the riskiest products subject to the highest level of controls, such as appropriate current good manufacturing standards established by [the] FDA," Hamburg’s testimony read.

Last month, the FDA released a copy of its inspection report of the NECC, saying that during an inspection of the pharmacy, inspectors found contaminated products and problems with the pharmacy’s ability to maintain its clean room, an enclosed space designed to have a controlled environment to ensure a sterile environment for drug compounding at the NECC’s Framingham, Mass., pharmacy.

The FDA said that the inspectors "observed conditions and practices that, in their judgment, may indicate violations of the Federal Food, Drug and Cosmetic Act, or related regulations," but that the report was not a formal determination that the NECC had committed any violations.

These included contamination with mold, bacteria and "foreign matter" in several areas and on equipment in the pharmacy designed to be kept sterile and sanitary. Inspectors found 83 vials of methylprednisolone acetate, the injectable steroid linked to the meningitis outbreak, that contained "greenish black foreign matter," while 17 contained "white filamentous material."

NEW YORK — The launch of a tamper-resistant formulation of a popular opioid painkiller in the United States, but not in Canada, may have influenced a spike in dispensing rate of the original at pharmacies in Canadian border cities, according to a study.

Researchers in Canada studies prescriptions dispensed from pharmacies at Niagara Falls, Windsor and Sarnia, Ontario, the cities with the highest volume of U.S.-Canada border crossings in the province. Analyzing data on outpatient prescriptions for Purdue Pharma’s OxyContin (oxycodone) extended-release tablets from April 2010 to February 2012, they calculated and compared monthly prescription rates, adjusted per 1,000 people. The study appeared online Tuesday in the Canadian journal Open Medicine.

The researchers found that the number of tablets dispensed near four border crossings in the three cities remained stable, but the rate of dispensing at pharmacies near the Detroit-Windsor Tunnel increased four-fold between August 2010 and February 2011, from 505 tablets per 1,000 people to 1,969, a number that declined to 1,683 in April 2011 following warnings to prescribers and pharmacies and then increasing again in November of that year. Overall, between August 2010 and October 2011, 242,075 "excess" tablets were dispensed near the Detroit-Windsor Tunnel.

According to published reports, the researchers were concerned about the effects that the launch of generic versions of OxyContin could have on health and safety as the drug, which remains a popular target for drug abusers and criminals, becomes more widespread.

As part of a panel at the recent Drug Store News Industry Issues Summit, officials from Walmart and Kroger shared the ways the two organizations go about taking a collaborative approach to health care.

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